Ablation probe with flared electrodes

ABSTRACT

An ablation device includes a cannula having a proximal end, a distal end, and a lumen extending between the proximal and the distal ends, and a first array of electrodes at least partially disposed within the lumen, the first array of electrodes slidable relative to the cannula, each of the electrodes having a first configuration when inside the lumen, and a second configuration when unconfined outside the lumen, wherein one of the electrodes has a flared deployed profile.

FIELD OF THE INVENTION

The field of the invention relates generally to radio frequency (RF)electrosurgical probes for the treatment of tissue, and moreparticularly, to electrosurgical probes having multipletissue-penetrating electrodes that are deployed in an array to treatvolumes of tissue.

BACKGROUND OF THE INVENTION

Tissue may be destroyed, ablated, or otherwise treated using thermalenergy during various therapeutic procedures. Many forms of thermalenergy may be imparted to tissue, such as radio frequency electricalenergy, microwave electromagnetic energy, laser energy, acoustic energy,or thermal conduction. In particular, radio frequency ablation (RFA) maybe used to treat patients with tissue anomalies, such as liver anomaliesand many primary cancers, such as cancers of the stomach, bowel,pancreas, kidney and lung. RFA treatment involves destroying undesirablecells by generating heat through agitation caused by the application ofalternating electrical current (radio frequency energy) through thetissue.

Various RF ablation devices have been suggested for this purpose. Forexample, U.S. Pat. No. 5,855,576 describes an ablation apparatus thatincludes a plurality of electrode tines deployable from a cannula. Eachof the tines includes a proximal end that is coupled to a generator, anda distal end that may project from a distal end of the cannula. Thetines are arranged in an array with the distal ends located generallyradially and uniformly spaced apart from the distal end of the cannula.The tines may be energized in a bipolar mode (i.e., current flowsbetween closely spaced electrode tines) or a monopolar mode (i.e.,current flows between one or more electrode tines and a larger, remotelylocated common electrode) to heat and necrose tissue within a preciselydefined volumetric region of target tissue. To assure that the targettissue is adequately treated and/or to limit damaging adjacent healthytissues, the array of tines may be arranged uniformly, e.g.,substantially evenly and symmetrically spaced-apart so that heat isgenerated uniformly within the desired target tissue volume.

When using the above described devices in percutaneous interventions,the cannula is generally inserted through a patient's skin, and thetines are deployed out of the distal end of the cannula to penetratetarget tissue. Particularly, the tines are deployed such that the distalends of the tines initially exit from a distal opening at the cannula.As the tines are further deployed, the distal ends of the tines evertradially away from an axis of the cannula, and then back towards aproximal end of the cannula (so that they face substantially in theproximal direction when fully deployed). As such, the tines/electrodesof the above described device each has a profile that resembles aparabola after the electrodes are deployed. The tines are then energizedto ablate the target tissue.

It has been found that deployed electrodes having parabolic profileshave relatively low column strength, thereby allowing the electrodes toeasily buckle. The buckling of the electrodes may occur within thecannula as the electrodes are being advanced within the cannula. Inother cases, the buckling of the electrodes may occur outside thecannula as the electrodes penetrate through tissue (e.g., dense tissue).This is especially true with ablation probes that are used to createlarge size lesions. In such cases, longer wires are used in order tocreate longer tines, such that the array of tines will span acrosstissue have a certain size (e.g., cross-sectional area/dimension) whenthe tines are deployed. Since a column strength of a tine is inverselyproportional to the length of the tine, creating tines using long wireswill cause the tines to have low column strength. In some cases, thecross-sectional size of a tine can be increased to improve the tine'scolumn strength. However, increasing the cross-sectional size of thetines increases the overall size of the ablation probe, making theablation probe less desirable for treatment.

Ablation devices having a flat electrode array have been described inU.S. patent application Ser. No. 10/668,995. In such devices, theelectrodes have a sharp 90° bent followed by a substantiallyflat/straight profile, such that the electrodes extend in directionsthat are substantially perpendicular to a longitudinal axis of thecannula when deployed from the cannula. Such configuration isparticularly beneficial for generating flat lesions. However, in somecases, it may be desirable to generate lesions that are relatively morevoluminous. Also, electrodes having the above configuration may undergoexcessive bending stress (because of the sharp 90° bent) when housedwithin a cannula, and may be difficult to be deployed from the cannula.

Thus, there remains a need to provide for improved ablation deviceshaving electrodes with good column strength. There is also a need toprovide for improved electrodes that can be housed within a cannulawithout inducing excessive stress on the electrodes.

Another problem associated with existing ablation devices is that theytend to create lesions that are symmetrical. For example, anotherexisting ablation device includes two electrode arrays that are spacedfrom each other, wherein the arrays have the same configuration (e.g.,same deployed profile and same number of electrodes). Such ablationdevices create lesions that are substantially symmetrical. However, insome cases, it may be desirable to create lesions that are asymmetric,or lesions that have other customized shapes.

SUMMARY OF THE INVENTION

In accordance with some embodiments, an ablation device includes acannula having a proximal end, a distal end, and a lumen extendingbetween the proximal and the distal ends, and a first array ofelectrodes at least partially disposed within the lumen, the first arrayof electrodes slidable relative to the cannula, each of the electrodeshaving a first configuration when inside the lumen, and a secondconfiguration when unconfined outside the lumen, wherein a distalportion of one of the electrodes has a curvilinear body, and an anglebetween an axis of the cannula and an instantaneous tangent at a pointalong the distal portion of the body is 120° or less when the one of theelectrodes is in the second configuration.

In accordance with other embodiments, a method of placing an array ofelectrodes within a tissue includes placing at least a portion of acannula within a body, the cannula having a lumen, and deploying anarray of electrodes having curvilinear distal portions outside the lumensuch that an angle between the axis of the cannula and an instantaneoustangent at a point along the distal portion of one of the electrodes is120° or less when the one of the electrodes is fully deployed.

In accordance with other embodiments, an ablation device includes acannula having a proximal end, a distal end, and a lumen extendingbetween the proximal and the distal ends, and a first array ofelectrodes at least partially disposed within the lumen, the first arrayof electrodes slidable relative to the cannula, each of the electrodeshaving a first configuration when inside the lumen, and a secondconfiguration when unconfined outside the lumen, wherein one of theelectrodes has a shape that resembles a half-parabola when in the secondconfiguration.

In accordance with other embodiments, a method of placing an array ofelectrodes within a tissue includes placing at least a portion of acannula within a body, the cannula having a lumen, and deploying anarray of electrodes outside the lumen, wherein one of the deployedelectrodes has a shape that resembles a half-parabola when theelectrodes are deployed.

In accordance with other embodiments, an ablation device includes acannula having a proximal end, a distal end, and a lumen extendingbetween the proximal and the distal ends, and a first array ofelectrodes at least partially disposed within the lumen, the first arrayof electrodes slidable relative to the cannula, each of the electrodeshaving a first configuration when inside the lumen, and a secondconfiguration when unconfined outside the lumen, wherein one of theelectrodes has a flared deployed profile.

In accordance with other embodiments, a method of placing an array ofelectrodes within a tissue includes placing at least a portion of acannula within a body, the cannula having a lumen, and deploying anarray of electrodes outside the lumen, wherein one of the electrodes hasa flared profile when in the second configuration.

In accordance with other embodiments, an ablation device includes acannula having a distal opening, and a lumen in communication with thedistal opening, and a first array of electrodes at least partiallydisposed within the lumen, the first array of electrodes, each of theelectrodes having a first configuration when inside the lumen, and asecond configuration when unconfined outside the lumen, wherein each ofthe electrodes has a distal tip located distal to the distal openingwhen the each of the electrodes is fully deployed, and a longitudinalspacing between the distal tip of one of the electrodes and the distalopening is at least 20% of the length of the one of the electrodes.

In accordance with other embodiments, a method of placing an array ofelectrodes within a tissue includes placing at least a portion of acannula within a body, the cannula having a distal opening and a lumenin communication with the distal opening, and deploying an array ofelectrodes outside the lumen such that distal tips of the respectiveelectrodes are distal to the distal opening, and a longitudinal spacingbetween the distal tip of one of the electrodes and the distal openingis at least 20% of the length of the one of the electrodes.

Other and further aspects and features of the invention will be evidentfrom reading the following detailed description of the preferredembodiments, which are intended to illustrate, not limit, the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of preferred embodimentsof the present invention. It should be noted that the figures are notdrawn to scale and that elements of similar structures or functions arerepresented by like reference numerals throughout the figures. In orderto better appreciate how the above-recited and other advantages andobjects of the present inventions are obtained, a more particulardescription of the present inventions briefly described above will berendered by reference to specific embodiments thereof, which areillustrated in the accompanying drawings. Understanding that thesedrawings depict only typical embodiments of the invention and are nottherefore to be considered limiting of its scope, the invention will bedescribed and explained with additional specificity and detail throughthe use of the accompanying drawings in which:

FIG. 1 is a schematic diagram of a tissue ablation system in accordancewith some embodiments of the invention;

FIG. 2 is a perspective view of an ablation probe used in the system ofFIG. 1, wherein an electrode array is particularly shown retracted;

FIG. 3 is a perspective view of an ablation probe used in the system ofFIG. 1, wherein an electrode array is particularly shown deployed;

FIG. 4 is a side view of an ablation probe in accordance with otherembodiments of the invention, showing the ablation probe having anelectrode secured to a cannula;

FIG. 5 is a side view of a distal end of the ablation probe of FIG. 1;

FIG. 6 is a side view of a distal end of an ablation probe in accordancewith other embodiments of the invention;

FIGS. 7A-7D are cross-sectional views, showing a method for treatingtissue, in accordance with some embodiments of the invention;

FIG. 8 is a side view of an ablation probe having two electrode arraysin accordance with other embodiments of the invention;

FIG. 9 is a side view of an ablation probe having two electrode arraysin accordance with other embodiments of the invention, showing thearrays being deployed by separate shafts;

FIG. 10 is a side view of an ablation probe in accordance with otherembodiments of the invention, showing the ablation probe having twoarrays of electrodes facing in opposite directions;

FIG. 11 is a side view of an ablation probe in accordance with otherembodiments of the invention, showing the ablation probe having twoarrays of electrodes that are slidable relative to each other;

FIG. 12 is a side view of an ablation probe in accordance with otherembodiments of the invention, showing the ablation probe having twoelectrode arrays with different configurations;

FIG. 13 is a side view of an ablation probe in accordance with otherembodiments of the invention, showing the ablation probe having twoelectrode arrays with different configurations; and

FIGS. 14A-14D are cross-sectional views, showing a method for treatingtissue, in accordance with some embodiments of the invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

FIG. 1 illustrates a tissue ablation system 2 constructed in accordancewith one embodiment of the invention. The tissue ablation system 2generally includes a probe assembly 4 configured for introduction intothe body of a patient for ablative treatment of target tissue, and aradio frequency (RF) generator 6 configured for supplying RF energy tothe probe assembly 4 in a controlled manner.

Referring specifically now to FIGS. 2 and 3, the probe assembly 4includes an elongate cannula 12, a shaft 20 slidably disposed within thecannula 12, and a plurality of electrodes 26 carried by the shaft 20.The cannula 12 has a distal end 14, a proximal end 16, and a centrallumen 18 extending through the cannula 12 between the distal end 14 andthe proximal end 16. The cannula 12 may be rigid, semi-rigid, orflexible depending upon the designed means for introducing the cannula12 to the target tissue. The cannula 12 is composed of a suitablematerial, such as plastic, metal or the like, and has a suitable length,typically in the range from 5 cm to 30 cm, preferably from 10 cm to 20cm. The length of the cannula 12 can also have other dimensions. Ifcomposed of an electrically conductive material, the cannula 12 ispreferably covered with an insulative material. The cannula 12 has anoutside cross sectional dimension consistent with its intended use,typically being from 0.5 mm to 5 mm, usually from 1.3 mm to 4 mm. Thecannula 12 may have an inner cross sectional dimension in the range from0.3 mm to 4 mm, preferably from 1 mm to 3.5 mm. The cannula 12 can alsohave other outside and inner cross sectional dimensions in otherembodiments.

It can be appreciated that longitudinal translation of the shaft 20relative to the cannula 12 in a distal direction 40 deploys theelectrode tines 26 from the distal end 14 of the cannula 12 (FIG. 3),and longitudinal translation of the shaft 20 relative to the cannula 12in a proximal direction 42 retracts the shaft 20 and the electrode tines26 into the distal end 14 of the cannula 12 (FIG. 2). The shaft 20comprises a distal end 22 and a proximal end 24. Like the cannula 12,the shaft 20 is composed of a suitable material, such as plastic, metalor the like.

In the illustrated embodiment, each electrode 26 takes the form of anelectrode tine, which resembles the shape of a needle or wire. Each ofthe electrodes 26 is in the form of a small diameter metal element,which can penetrate into tissue as it is advanced from a target sitewithin the target region. In some embodiments, distal ends 66 of theelectrodes 26 may be honed or sharpened to facilitate their ability topenetrate tissue. The distal ends 66 of these electrodes 26 may behardened using conventional heat treatment or other metallurgicalprocesses. They may be partially covered with insulation, although theywill be at least partially free from insulation over their distalportions.

When deployed from the cannula 12, the array 30 of electrodes 26 has adeployed configuration that defines a volume having a periphery with aradius in the range from 0.5 to 4 cm. However, in other embodiments, themaximum radius can be other values. The electrodes 26 are resilient andpre-shaped to assume a desired configuration when advanced into tissue.In the illustrated embodiment, the electrodes 26 diverge radiallyoutwardly from the cannula 12 in a uniform pattern, i.e., with thespacing between adjacent electrodes 26 diverging in a substantiallyuniform and/or symmetric pattern. The profile of the electrodes 26 willbe described in further details below.

It should be noted that although a total of two electrodes 26 areillustrated in FIG. 3, in other embodiments, the probe assembly 4 canhave more or fewer than two electrodes 26. In exemplary embodiments,pairs of adjacent electrodes 26 can be spaced from each other in similaror identical, repeated patterns and can be symmetrically positionedabout an axis of the shaft 20. It will be appreciated that a widevariety of particular patterns can be provided to uniformly cover theregion to be treated. In other embodiments, the electrodes 26 may bespaced from each other in a non-uniform pattern.

The electrodes 26 can be made from a variety of electrically conductiveelastic materials. Very desirable materials of construction, from amechanical point of view, are materials which maintain their shapedespite being subjected to high stress. Certain “super-elastic alloys”include nickel/titanium alloys, copper/zinc alloys, or nickel/aluminumalloys. Alloys that may be used are also described in U.S. Pat. Nos.3,174,851, 3,351,463, and 3,753,700, the disclosures of which are herebyexpressly incorporated by reference. The electrodes 26 may also be madefrom any of a wide variety of stainless steels. The electrodes 26 mayalso include the Platinum Group metals, especially platinum, rhodium,palladium, rhenium, as well as tungsten, gold, silver, tantalum, andalloys of these metals. These metals are largely biologically inert.They also have significant radiopacity to allow the electrodes 26 to bevisualized in-situ, and their alloys may be tailored to accomplish anappropriate blend of flexibility and stiffness. They may be coated ontothe electrodes 26 or be mixed with another material used forconstruction of the electrodes 26.

The electrodes 26 have generally uniform widths and rectangularcross-sections. The rectangular cross-sections make the electrodes 26stiffer in one direction (e.g., the transverse direction) and moreflexible in another direction (e.g., the radial direction). Byincreasing transverse stiffness, proper circumferential alignment of theelectrodes 26 within the lumen 18 of the cannula 12 is enhanced. Inother embodiments, the widths of the electrodes 26 may be non-uniform,and the cross-sections of the electrodes 26 may be non-rectangular.Exemplary electrodes will have a width (in the circumferentialdirection) in the range from 0.2 mm to 0.6 mm, preferably from 0.35 mmto 0.40 mm, and a thickness (in the radial direction) in the range from0.05 mm to 0.3 mm, preferably from 0.1 mm to 0.2 mm.

In the illustrated embodiments, the RF current is delivered to theelectrode array 30 in a monopolar fashion, which means that current willpass from the electrode array 30, which is configured to concentrate theenergy flux in order to have an injurious effect on the surroundingtissue, and a dispersive electrode (not shown), which is locatedremotely from the electrode array 30 and has a sufficiently large area(typically 130 cm² for an adult), so that the current density is low andnon-injurious to surrounding tissue. In the illustrated embodiment, thedispersive electrode may be attached externally to the patient, e.g.,using a contact pad placed on the patient's flank.

Alternatively, the RF current is delivered to the electrode array 30 ina bipolar fashion, which means that current will pass between twoelectrodes (“positive”(or active) and “negative”(or passive/return)electrodes) of the electrode array 30, or between the electrodes of theelectrode array 30 and the electrodes of another array (“positive”(oractive) and “negative”(or passive/return) electrode arrays). In abipolar arrangement, the positive and negative electrodes or electrodearrays will be insulated from each other in any regions where they wouldor could be in contact with each other during the power delivery phase.In other embodiments, the probe assembly 4 can further include anelectrode 90 secured to the cannula 12 (FIG. 4). In such cases, theelectrodes 26 in the array 30 can be active electrodes while theelectrode 90 functions as return electrode for completing energypath(s). Alternatively, the electrode 90 can be active electrode whilethe electrodes 26 in the array 30 functions as return electrodes forcompleting energy path(s).

Returning to FIGS. 2 and 3, the probe assembly 4 further includes ahandle assembly 27, which includes a handle portion 28 mounted to theproximal end 24 of the shaft 20, and a handle body 29 mounted to theproximal end 16 of the cannula 12. The handle portion 28 is slidablyengaged with the handle body 29 (and the cannula 20). The handle portion28 also includes an electrical connector 38, which allows the probeassembly 2 to be connected to the generator 6 during use. The electricalconnector 38 is electrically coupled to the electrodes 26. As will bedescribed in further detail below, the electrical connector 38 can beconveniently coupled to the electrodes 26 via the shaft 20 (which willbe electrically conductive), although in other embodiments, theconnector 38 can be coupled to the electrodes 26 via separate wires (notshown). The handle portion 28 and the handle body 29 can be composed ofany suitable rigid material, such as, e.g., metal, plastic, or the like.

Optionally, a marker (not shown) may be placed on the handle portion 28and/or on the proximal end 24 of the shaft 20 for indicating arotational orientation or a position of the handle portion 28 relativeto the shaft 20 (and the electrodes 26) during use. In some embodiments,the handle assembly 27 can have an indexing feature. For example, theproximal end 24 of the shaft 20 or the handle portion 28 can have one ormore keys that mate with respective slot(s) at the interior surface ofthe cannula 12 or the handle body 29. Such indexing feature allowscircumferential alignment of the shaft 20 (and the array 30) relative tothe cannula 12. Angle indexing devices that may be used include thosedescribed in U.S. patent application Ser. No. 10/317,796, entitled“Angle Indexer For Medical Devices”, the entire disclosure of which isexpressly incorporated by reference herein. In other embodiments, thehandle portion 28 may also include a locking mechanism (not shown) totemporarily lock against the shaft 20 to provide a more stable indexing.For example, the locking mechanism may include an axially-sliding clutchassembly that is slidable along an axis of the shaft 20 to therebysecure the handle portion 28 against the shaft 20. Other securingdevices known in the art may also be used.

Referring back to FIG. 1, the RF generator 6 is electrically connectedto the electrical connector 38, which may be directly or indirectly(e.g., via a conductor) electrically coupled to the electrode array 30.The RF generator 6 is a conventional RF power supply that operates at afrequency in the range from 200 KHz to 1.25 MHz, with a conventionalsinusoidal or non-sinusoidal wave form. Such power supplies areavailable from many commercial suppliers, such as Valleylab, Aspen, andBovie. Most general purpose electrosurgical power supplies, however,operate at higher voltages and powers than would normally be necessaryor suitable for vessel occlusion. Thus, such power supplies wouldusually be operated at the lower ends of their voltage and powercapabilities. More suitable power supplies will be capable of supplyingan ablation current at a relatively low voltage, typically below 150V(peak-to-peak), usually being from 50V to 100V. The power will usuallybe from 20 W to 200 W, usually having a sine wave form, although otherwave forms would also be acceptable. Power supplies capable of operatingwithin these ranges are available from commercial vendors, such asBoston Scientific Corporation of San Jose, Calif., which markets thesepower supplies under the trademarks RF2000 (100 W) and RF3000 (200 W).

Referring now to FIG. 5, in which the profiles of the electrodes 26 areshown. In the illustrated embodiments, each electrode 26 has a flaredcurvilinear profile that resembles a quarter (25%) of a circular profileor elliptical profile (or a half parabola). Such configuration providesa same radius 130 of span as that for an existing electrode having aparabolic profile (shown in dotted-lines in the figure), while allowingthe electrode 26 to have a shorter length than existing electrodes. Assuch, the electrodes 26 having the configuration shown in FIG. 5 hasbetter column strength, and is advantageous over existing electrodesthat have parabolic profiles. It should be noted that the electrodes 26should not be limited to having flared profiles that resembles a quarterof a circular or elliptical profile, and that in alternativeembodiments, the electrodes 26 can each have a flared profile thatresembles other portions of a circular or elliptical profile. As used inthe specification, the term “flared” is used to describe a profile of anelectrode having a deployed shape that extends away from an axis, doesnot have a symmetric parabolic profile, and is not rectilinear along asubstantial portion of its length.

Another inventive aspect of the electrodes 26 is that a distal tip 120of each electrode 26 is longitudinally spaced at a distance 104 that isdistal from an exit point 102 (the point at which the electrodes 26 exitfrom the cannula 12). Such configuration prevents, or at least reducethe risk of, bending of electrodes 26 as they are deployed, therebyensuring that a deployed electrode 26 will span a radius 130 that issubstantially the same as that intended. This is advantageous overexisting electrodes that have symmetric parabolic profiles, in whichcase, a bending of an electrode may result in a deployed electrodehaving a span radius 130 that is smaller or larger than that originallyintended. The curvilinear profile of the electrodes 26 shown in theillustrated embodiments is also advantageous over deployed electrodesthat are substantially straight and extend substantially perpendicularto an axis of the cannula in that the curvilinear profile reduces stresson the electrodes 26 when the electrodes 26 are bent and confined withinthe cannula. The curvilinear profile also allows the electrodes 26 toexit easily from the cannula 12 as the electrodes 26 are deployed. Insome embodiments, the distance 104 is equal to at least 20% of thelength of an electrode 26.

In other embodiments, the profile of each electrode 26 can becharacterized by the fact that an instantaneous tangent 110 at a point(e.g, a distal tip 120) along a distal portion 102 of the electrode 26forms an angle 114 that is between 45° and 120°, and more preferably,between 80° and 100° (e.g., approximately 90°), from an axis 100 of thecannula 12. In the illustrated embodiments, the distal portion 102includes a distal 5%, and more preferably, a distal 10%, of the lengthof the deployed electrode 26. In other embodiments, the distal portion102 can include more than a distal 10% (e.g., 50%) of the length of thedeployed electrode 26.

It should be noted that the shape and configuration of the electrodes 26should not be limited to that described previously, and that theelectrodes 26 may have other pre-formed shapes. For example, in otherembodiments, the array 30 of electrodes 26 can have a deployedconfiguration that resembles a cone (FIG. 6).

Referring now to FIGS. 7A-7D, the operation of the tissue ablationsystem 2 is described in treating a treatment region TR within tissue Tlocated beneath the skin or an organ surface S of a patient. The cannula12 is first introduced within the treatment region TR, so that thedistal end 14 of the cannula 12 is located at the target site TS, asshown in FIG. 7B. This can be accomplished using any one of a variety oftechniques. In some cases, the cannula 12 and shaft 20 may be introducedto the target site TS percutaneously directly through the patient's skinor through an open surgical incision. In this case, the cannula 12 mayhave a sharpened tip, e.g., in the form of a needle, to facilitateintroduction to the target site TS. In such cases, it is desirable thatthe cannula 12 be sufficiently rigid, i.e., have a sufficient columnstrength, so that it can be accurately advanced through tissue T. Inother cases, the cannula 12 may be introduced using an internal styletthat is subsequently exchanged for the shaft 20 and electrode array 30.In this latter case, the cannula 12 can be relatively flexible, sincethe initial column strength will be provided by the stylet. Morealternatively, a component or element may be provided for introducingthe cannula 12 to the target site TS. For example, a conventional sheathand sharpened obturator (stylet) assembly can be used to initiallyaccess the tissue T. The assembly can be positioned under ultrasonic orother conventional imaging, with the obturator/stylet then removed toleave an access lumen through the sheath. The cannula 12 and shaft 20can then be introduced through the sheath lumen, so that the distal end14 of the cannula 12 advances from the sheath to the target site TS.

After the cannula 12 is properly placed, the shaft 20 is distallyadvanced to deploy the electrode array 30 radially outward from thedistal end 14 of the cannula 12, as shown in FIG. 7C. The shaft 20 willbe advanced sufficiently, so that the electrode array 30 is fullydeployed to span at least a portion of the treatment region TR, as shownin FIG. 7D. Alternatively, the needle electrodes 26 may be onlypartially deployed or deployed incrementally in stages during aprocedure. The inventive profile of the needle electrodes 26 prevents,or at least reduces the chance of, buckling of the electrodes 26 as theelectrodes 26 are being deployed.

Next, the RF generator 6 is then connected to the probe assembly 4 (or200) via the electrical connector 38, and the RF generator 6 is operatedto deliver ablation energy to the needle electrodes 26 either in aunipolar mode or a bipolar mode. As a result, the treatment region TR isnecrosed, thereby creating a lesion on the treatment region TR.

In many cases, a single ablation may be sufficient to create a desiredlesion. However, if it is desired to perform further ablation toincrease the lesion size or to create lesions at different site(s)within the treatment region TR or elsewhere, the needle electrodes 26may be introduced and deployed at different target site(s), and the samesteps discussed previously may be repeated. When a desired lesion attreatment region TR has been created, the needle electrodes 26 areretracted into the lumen 18 of the cannula 12, and the probe assembly 4is removed from the treatment region TR.

Although the probe assembly 4 has been described as having a singlearray of electrodes, in other embodiments, the probe assembly 4 caninclude more than one array of electrodes 26. FIG. 8 illustrates a probeassembly 200 having a plurality of arrays of electrodes in accordancewith other embodiments of the invention. The probe assembly 200 includesan elongate cannula 212, a shaft 220 slidably disposed within thecannula 212, and a first array 225 of electrodes 226 carried by theshaft 220. The cannula 212 has a distal end 214, a proximal end 216, anda central lumen 218 extending through the cannula 212 between the distalend 214 and the proximal end 216. The electrodes 226 have the sameprofiles as the electrodes 26 described previously.

The probe assembly 200 further includes a second array 250 of electrodes256 slidably disposed within the cannula 212. In the illustratedembodiments, the second array 250 is secured to the shaft 220. As such,distal advancement of the shaft 220 will deploy both the first and thesecond arrays 225, 250 of electrodes. The cannula 212 further includesopenings 280 through its wall for allowing the electrodes 256 to exitfrom the lumen 218 when they are deployed.

The electrodes 226 in the first array 225 are active electrodes whilethe electrodes 256 in the second array 250 are passive/returnelectrodes, thereby allowing the arrays 225, 250 to be operated in abipolar arrangement. Alternatively, the electrodes 226 in the firstarray 225 are passive/return electrodes while the electrodes 256 in thesecond array 250 are active electrodes. Also, in other embodiments, theelectrodes in both arrays 226, 256 can be active electrodes. In suchcases, an electrode pad can be placed on a patient's skin to completethe energy path, thereby allowing the arrays 226, 256 of electrodes tobe operated in a monopolar arrangement. In further embodiments, one ormore electrodes 226 in the first array 225 can be active electrode(s)that operate in a bipolar arrangement with another electrode 226(serving as a return electrode) in the first array 225. Similarly, oneor more electrodes 256 in the second array 250 can be activeelectrode(s) that operate in a bipolar arrangement with anotherelectrode 256 (serving as a return electrode) in the second array 250.In some embodiments, one or more of the electrodes in the first and thesecond arrays 226, 256 can have portion(s) that is electricallyinsulated to achieve desired energy path(s).

In other embodiments, instead of securing the second array 250 to thesame shaft 220, the second array 250 is secured to another shaft 290having a lumen 292 (FIG. 9). In such cases, the first shaft 220 isdisposed within the lumen 292 of the second shaft 290. The second array250 of electrodes can be deployed through the openings 280, oralternatively, if the cannula 212 does not have the openings 280,through the distal opening 282 at the distal end 214 of the cannula 212.The first array 225 of electrodes 226 can be deployed by advancing theshaft 220 distally relative to the cannula 212 until the electrodes 226are unconfined outside the lumen 218 of the cannula 212, and the secondarray 250 of electrodes 256 can be deployed by advancing the shaft 290distally relative to the cannula 212 until the electrodes 256 areunconfined outside the lumen 218 of the cannula 212. In the illustratedembodiments, the probe assembly 200 includes a handle assembly 293having a handle body 294, a first handle portion 295 secured to aproximal end 224 of the first shaft 220, and a second handle portion 296secured to a proximal end 293 of the second shaft 290. The first handleportion 295 and the second handle portion 296 can be positioned relativeto the handle body 294 for deploying the first and the second arrays225, 250, respectively.

In the illustrated embodiments, the electrodes 256 in the second array250 have profiles that are the same or similar to those of theelectrodes 226 in the first array 225, and the two arrays 225, 250 facetowards the same direction. In other embodiments, instead of having thetwo arrays 225, 250 of electrodes facing towards the same direction, thetwo arrays of electrodes can face towards each other in oppositedirections (FIG. 10). In such cases, the second array 250 of electrodes256 are deployed out of the openings 280 by retracting the second handleportion 296 proximally relative to the handle body 294, and the firstarray 225 of electrodes 226 are deployed out of the distal opening 282by advancing the first handle portion 295 distally relative to thehandle body 294.

It should be noted that although a total of two electrodes areillustrated for each of the arrays 225, 250 in FIGS. 8-10, in otherembodiments, the probe assembly 200 can have more or fewer than twoelectrodes per array.

In the above embodiments, the electrodes 256 are deployed out of thecannula 212 via the openings 280. Alternatively, the electrodes 256 canbe deployed through the distal opening 282 of the cannula 212. FIG. 11illustrates an ablation probe 300 in accordance with other embodimentsof the invention. The probe assembly 300 includes an elongate cannula312, a first shaft 330, a first array 325 of electrodes 326 secured to adistal end 332 of the first shaft 330, a second shaft 320, and a secondarray 350 of electrodes 356 secured to a distal end 322 of the secondshaft 320. The cannula 312 has a distal end 314, a proximal end 316, anda central lumen 318 extending through the cannula 312 between the distalend 314 and the proximal end 316. The electrodes 326, 356 have the sameprofiles as the electrodes 26 described previously.

In the illustrated embodiments, the first shaft 330 is slidably disposedwithin a lumen 328 of the second shaft 320, and the second shaft 320 isslidably disposed within the lumen 318 of the cannula 312. The secondarray 350 can be deployed by advancing the second shaft 320 distallyrelative to the cannula 312 (or retracting the cannula 312 proximallyrelative to the second shaft 320) until the second array 350 ofelectrodes 356 exit from a distal opening 360 at the distal end 314 ofthe cannula. The first array 325 can be deployed by advancing the firstshaft 330 distally relative to the second shaft 320 (or retracting thesecond shaft 320 proximally relative to the first shaft 330) until thefirst array 325 of electrodes 326 exit from a distal opening 362 at thedistal end 322 of the second shaft 320. Such configuration is beneficialbecause it allows a distance between the first and the second arrays tobe adjusted during use. It should be noted that the probe assembly 300should not be limited to electrodes having the illustrated deployedprofiles, and that in other embodiments, one or both of the arrays 325,350 can have electrodes with other deployed profiles. For example, anelectrode in the first array 325 (and/or an electrode in the secondarray 350) can have a parabolic profile, a rectilinear profile, or acustomized profile in other embodiments.

In the above embodiments, electrodes in the first and the second arrayshave the same deployed profiles. In other embodiments, electrodes in thefirst array can have deployed profiles that are different fromelectrodes in the second array. Such feature is advantageous in that itallows lesions having asymmetric profile to be created. For example, insome embodiments, the electrodes 326 in the first array 325 each has adeployed profile that resembles a parabola, while the electrodes 356 inthe second array 350 each has a flared deployed profile that is similarto that shown in FIG. 5 (FIG. 12). Alternatively, the electrodes 326 inthe first array 325 can each have a flared deployed profile that issimilar to that shown in FIG. 5, while the electrodes 356 in the secondarray 350 each has a parabolic deployed profile. In other embodiments,the electrodes 326 in the first array 325 each has a deployed profilethat resembles a parabola, while the electrodes 356 in the second array350 each has a flared deployed profile that is similar to that shown inFIG. 6 (with the deployed array 356 having a configuration thatresembles a cone) (FIG. 13). Alternatively, the electrodes 326 in thefirst array 325 can each have a flared deployed profile that is similarto that shown in FIG. 6, while the electrodes 356 in the second array350 each has a parabolic deployed profile. It should be noted thatalthough a total of two electrodes are illustrated for each of thearrays 325, 350 in FIGS. 11-13, in other embodiments, the probe assembly300 can have more or fewer than two electrodes per array.

It should be noted that the profiles of the deployed electrodes in thefirst and the second arrays 325, 350 should not be limited by theexamples illustrated previously, and that the electrodes in the firstand the second arrays 325, 350 can have other deployed profiles. Forexamples, in other embodiments, the electrodes in the first array 325(and/or the second array 350) can each have a straight or rectilineardeployed profile, a parabolic deployed profile, the flared deployedprofile shown in FIG. 5, or the flared profile shown in FIG. 6, or adeployed profile having a customized shape. Also, in other embodiments,instead of having the first and the second arrays 325, 350 facing thesame direction, the first and the second arrays 325, 350 can face in theopposite directions and towards each other. In addition, although theabove embodiments have been described as having the same number ofelectrodes per array, in any of the embodiments described herein, thefirst array 325 (or 225) and the second array 350 (or 250) can havedifferent number of electrodes. Further, in other embodiments, the firstarray 325 can have a radius (e.g., radius 130) of span that is differentfrom a radius of span of the second array 350. In such cases, the firstand the second arrays 325, 350 can have deployed shapes that are thesame or different. For example, in some embodiments, the second array350 has a radius of span that is greater than a radius of span of thefirst array 325, thereby allowing the arrays 325, 350 to create a lesionhaving a proximal end that is larger than a distal end. Alternatively,in other embodiments, the second array 350 has a radius of span that isless than a radius of span of the first array 325, thereby allowing thearrays 325, 350 to create a lesion having a proximal end that is smallerthan a distal end

Referring now to FIGS. 14A-14D, the operation of the tissue ablationprobe 300 is described in treating a treatment region TR within tissue Tlocated beneath the skin or an organ surface S of a patient. The cannula312 is first introduced within the treatment region TR, so that thedistal end 314 of the cannula 312 is located at the target site TS, asshown in FIG. 14A. This can be accomplished using any one of a varietyof techniques. In some cases, the cannula 312 and shafts 320, 330 may beintroduced to the target site TS percutaneously directly through thepatient's skin or through an open surgical incision. In this case, thecannula 312 may have a sharpened tip, e.g., in the form of a needle, tofacilitate introduction to the target site TS. In such cases, it isdesirable that the cannula 312 be sufficiently rigid, i.e., have asufficient column strength, so that it can be accurately advancedthrough tissue T. In other cases, the cannula 312 may be introducedusing an internal stylet that is subsequently exchanged for the shafts320, 330 and electrode arrays 325, 350. In this latter case, the cannula312 can be relatively flexible, since the initial column strength willbe provided by the stylet. More alternatively, a component or elementmay be provided for introducing the cannula 312 to the target site TS.For example, a conventional sheath and sharpened obturator (stylet)assembly can be used to initially access the tissue T. The assembly canbe positioned under ultrasonic or other conventional imaging, with theobturator/stylet then removed to leave an access lumen through thesheath. The cannula 312 and shafts 320, 330 can then be introducedthrough the sheath lumen, so that the distal end 314 of the cannula 312advances from the sheath to the target site TS.

After the cannula 312 is properly placed, the first shaft 330 isdistally advanced to deploy the first electrode array 325 radiallyoutward from the distal end 314 of the cannula 312, as shown in FIG.14B. The shaft 330 will be advanced sufficiently, so that the firstelectrode array 325 is fully deployed to span at least a portion of thetreatment region TR. Alternatively, the needle electrodes 326 may beonly partially deployed or deployed incrementally in stages during aprocedure.

After the electrodes 326 of the first array 325 have been deployed, thecannula 312, together with the second shaft 320 are then retractedproximally until the distal end 314 of the cannula 312 is desirablypositioned (FIG. 14C). The electrodes 356 of the second array 350 arethen advanced distally (e.g., by advancing the second handle portion 372distally relative to the handle body 370) until they exit from the lumen318 of the cannula 312, thereby deploying the second array 350 ofelectrodes 356 (FIG. 14D).

In alternative embodiments, instead of deploying the first array 325before the second array 350, the second array 350 can be deployed beforethe first array 325. In such cases, the second array 350 can be deployedby advancing the second handle portion 372 distally relative to thehandle body 370. After the second array 350 has been deployed, the firstarray 325, being confined within a sheath (not shown), is then advanceddistally together with the sheath until the distal end of the sheathexits from the lumen 328 of the second shaft 320 and is desirablypositioned. The sheath is then retracted proximally to deploy the firstarray 325 of electrodes 326.

Next, the RF generator 6 is then connected to the probe assembly 300,and the RF generator 6 is operated to deliver ablation energy to theneedle electrodes 326, 356 either in a unipolar mode or a bipolar mode.As a result, the treatment region TR is necrosed, thereby creating alesion on the treatment region TR. As a result of using arrays withdifferent configurations, the created lesion will have an asymmetricshape.

In many cases, a single ablation may be sufficient to create a desiredlesion. However, if it is desired to perform further ablation toincrease the lesion size or to create lesions at different site(s)within the treatment region TR or elsewhere, the needle electrodes 326,356 may be introduced and deployed at different target site(s), and thesame steps discussed previously may be repeated. When a desired lesionat treatment region TR has been created, the needle electrodes 326 areretracted into the lumen 328 of the second shaft 320, and the electrodes356 (together with the retracted electrodes 326) are retracted into thelumen 318 of the cannula 312. The probe assembly 300 is then removedfrom the treatment region TR.

Although the method has been described with reference to the ablationprobe 300, the same or similar method can be used with other embodimentsof ablation probe assembly described herein.

Although particular embodiments of the present invention have been shownand described, it should be understood that the above discussion is notintended to limit the present invention to these embodiments. It will beobvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present invention. For example, the array (e.g., array 30, 225, 250,325, or 350) of electrodes can be manufactured as a single component. Assuch, the “array of electrodes” should not be limited to a plurality ofseparate electrodes, and includes a single structure (e.g., anelectrode) having different conductive portions. Thus, the presentinvention is intended to cover alternatives, modifications, andequivalents that may fall within the spirit and scope of the presentinvention as defined by the claims.

1. An ablation device, comprising: a cannula having a distal tip and alumen extending within the cannula and terminating in an opening at thedistal tip; a first array of electrodes at least partially disposedwithin the lumen and deployable from the distal tip opening, the firstarray of electrodes slidable relative to the cannula, the first array ofelectrodes having a first configuration when inside the lumen, and asecond configuration when fully deployed outside the lumen; a secondarray of electrodes at least partially disposed within the lumen anddeployable from the lumen at a point of the cannula proximal to thedistal tip opening, the second array of electrodes slidable relative tothe cannula, the second array of electrodes having first configurationwhen inside the lumen, and a second configuration when fully deployedoutside the lumen, wherein a distal portion of every one of theelectrodes of the second array has a curvilinear body, the electrodes ofthe second array deploy from the cannula in a proximal direction, and adistal tip of the body of every one of the electrodes of the secondarray does not point in the distal direction when the second array ofelectrodes is in the second configuration; wherein a distal portion ofevery one of the electrodes of the first array has a curvilinear body,and a distal tip of the body of every one of the electrodes of the firstarray does not point in a proximal direction relative to the cannulawhen the first array of electrodes is in the second configuration andwherein the first and the second arrays of electrodes face towardsopposite directions when the arrays are outside the lumen of thecannula.
 2. The ablation device of claim 1, wherein the distal tip ofthe body of every one of the electrodes of the first array point in adistal direction relative to the cannula.
 3. The ablation device ofclaim 1, wherein every one of the electrodes of the first array has ashape that resembles a half-parabola when in the second configuration.4. The ablation device of claim 1, wherein every one of the electrodesof the first array does not have a symmetric parabolic shape when thefirst array of electrodes is in the second configuration.
 5. Theablation device of claim 1, wherein every one of the electrodes of thefirst array has a flared deployed profile.
 6. The ablation device ofclaim 1, wherein every one of the electrodes of the second array has aflared profile.
 7. The ablation device of claim 1, wherein alongitudinal spacing between the distal tip of every electrode of thefirst array and the distal tip opening is at least 20% of the length ofthe respective one of the electrodes of the first array.
 8. The ablationdevice of claim 1, wherein the longitudinal spacing between the distaltip of every one of the electrodes of the second array and the point ofthe cannula from which the second array deploys is at least 20% of thelength of the respective one of the electrodes of the second array.
 9. Amethod of placing first and second arrays of electrodes havingcurivilinear distal portions within tissue, comprising: placing at leasta portion of a cannula within a body, the cannula having a lumen thatterminates in an opening in the distal tip of the cannula; deploying thefirst array of electrodes from the distal tip opening, such that adistal tip of every one of the electrodes of the first array does notpoint in a proximal direction relative to the cannula when the firstarray of electrodes fully deployed; and deploying the second array ofelectrodes from at a point of the cannula proximal to the distal tipopening, wherein the electrodes of the second array deploy from thecannula in a proximal direction, and a distal tip of the body of everyone of the electrodes of the second array does not point in the distaldirection when the second array of electrodes is in the secondconfiguration.